Inspections, Compliance, Enforcement, and Criminal Investigations
R&P Seafood Corp. 8/16/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, CA 92612-2606
RETURN RECEIPT REQUESTED
August 16, 2010
Mr. Romel E. Perez
R&P Seafood Corp.
P.O. Box 336
Bell, CA 90201
Dear Mr. Perez:
We inspected your seafood processing facility, located at 649 Ceres Ave., Los Angeles, California on April 9, 12 and 14, 2010. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your histamine forming species including Tuna and Mahi-Mahi are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedures and frequency for histamine forming fish critical limit of "product shall be covered with ice" and "monitoring the presence of ice at the beginning and end of each shift and on a hourly basis" and "Cooler temperature maintained at 40°F or below" at the Cooler Step critical control point to control the hazard of "histamine formation during cooler storage". On 4/09/10, multiple tuna fillets were observed in the cooler that were not covered in ice. In addition, according to your February 2010 Cooler Log, the temperature of the cooler was not recorded at the end of the shift on 2/27/10.
2. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for (1) the safety of water that comes into contact with food or food contact surfaces including water used to manufacture ice; (2) condition and cleanliness of food contact surfaces; (3) prevention of cross-contamination from insanitary objects; (4) maintenance of hand washing, hand sanitizing, and toilet facilities; (5) protection of food, food packaging material and food contact surfaces from adulteration; (6) proper labeling, storage and use of toxic chemicals; (7) control of employee health conditions, and (8) exclusion of pests required for the processing of fresh tuna intended to be consumed raw. You did not document any monitoring on your firm's "Daily Sanitation Control Record" sheet, except for the dates 11/20/09, 11/21/09 and 11/23/09. In addition, there is not a specific area on your "Daily Sanitation Control Record" sheet to document corrections.
3. You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8(a)(2)(ii). However, your firm did not verify the calibration of process monitoring instruments, specifically the thermometer(s) used at the Storage critical control point to control histamine formation.
4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plan for Histamine Formers lists a monitoring frequency of Each Delivery -Each Badge [sic] at the Receiving Step critical control point that is not adequate to control Histamine Presence Formation During Transit. Your monitoring frequency does not specify how many cartons or fish will be monitored per delivery.
5. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for scombrotoxin producing fish at the Receiving critical control point to control to control histamine formation is not appropriate.
When the critical limit is exceeded, in that the ice is not adequate, a corrective action that involves taking the temperature of only one fish is not adequate to prevent the distribution of potentially unsafe fish. We recommend taking the temperatures of fish at various locations throughout the truck.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your film from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will Correct any remaining violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention:
Los Angeles District
Irvine, CA 92612-2506
If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.
Alonza E. Cruse
Los Angeles District
Sacramento, CA 95899-7413